Consultants Specializing in Regulatory Affairs for FDA Compliance

Quality System (Part 820 cGMP)


Smith Associates has developed implementation-ready Part 820 Quality Systems which includes SOPs with supporting logs and forms. The QS Part 820 is priced reasonably to meet quality system requirements from start-ups in the design phase to the small or large company, with Class I, II or III products. The SOPS, forms, WIs and Quality Manual have been reviewed by the FDA during inspections all over the United States and internationally, and will assist you in maintaining a stable and compliant FDA 820 cGMP System.

Quality System SOPs for Product Development under Design Control

Quality System begins with a Design Review meeting in order to leave the design concept and feasibility phase.

Your medical product must be developed according to Part 820.30 Design Control. Once you are ready to leave Design Feasibility/Concept Phase make sure you have your complete Design Control Quality System reviewed, approved and implemented. The paperwork generated under Design Control will provide the necessary test reports and labeling information required for your 510(k) and the Design History File and DMR will be readily available for an FDA Inspection.

FDA expects your company to manufacture your device or IVD with a fully implemented and working quality system prior to marketing your medical device. The number one problem we have found is formal Design Review meetings were not held or documented between the various design and development stages.

We can supply you with implementation ready standard operating procedures and forms to meet the requirements of 820.180 and 820.198. All you need to do is review, approve and implement.

Quality System 820 SOPs for ISO 13485 Gaps

Most of the medical device manufactures around the globe have implemented ISO 13485 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes and so have thousands of medical device companies in the United States who market their medical devices outside the United States.

We spend a good portion of each year attending FDA Inspections of our clients. Over the past three years I have noticed the FDA focusing their attention on Design Control activities, such as design history files (DHF), device master records (DMR), device history record (DHR), complaint handling and medical device reporting, etc. Many of these topics sound similar between the ISO 13485 and Part 820 Quality Systems but they are not. Smith Associates knows the differences between the two Quality Systems and can provide standard operating procedures, logs and forms that cover the needs of both the ISO and FDA Quality System’s requirements. The only task you need to perform is review, approve and implement and the differences between the two systems disappear.

Make sure you are ready for your next FDA Inspection.

Quality System SOPs for the start-up, medium or large medical device companies with pricing to fit your needs

Many medical device companies are small to medium size with fewer than 50 employees and have limited personnel to act as a Quality System Manager. However, FDA still requires the manufacturer to maintain a Quality System which meets all the requirements of Part 820 of the Code of Federal Regulations.

Smith Associates was formed in January 1994 to help small and medium size medical device firms achieve FDA clearances without breaking their financial backs. When your firm receives the FDA clearance letter the third paragraph states the following:

“Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.”

This means you need to be manufacturing your medical device under a quality system in order to be compliant with the applicable Codes of Federal Regulations.

Smith Associates can offer you a COMPLETE Quality System that fulfills all of the requirements of 21 CFR 820. All you have to do is review, approve and implement the quality system. We offer two quality systems, 1) start-up or very small manufacturers and 2) medium to large medical device manufacturers. We also supply support and training if necessary.

Quality System SOPS for the Specification Developer

Since I am not manufacturing the product do I still need a quality system? Yes, you still need a Quality System.

Even though you have subcontracted many of these responsibilities to another company, the FDA inspector would still expect to see original engineering drawings, design history files, device master records, device history files, records of all nonconforming products, complaints, medical device reports, etc. to be available at the Specification Developer’s place of business. The FDA holds the 510(k) Owner/Sponsor responsible for all quality system activities whether at your place of business or your subcontractor’s place of business to insure that the product they cleared is the product being produced and sold in the United States.

In conclusion you need to make sure you have a strong quality system in place in order to pass FDA Inspections.

Quality System SOPs for the Initial Importer

If I am an Initial Importer do I need a Quality System? The answer to that is a yes, but only parts that are assigned to you by the manufacturer. If you are an initial importer your contract should specify what quality system duties have been subcontracted to your firm. Find out what Code of Federal Regulation you are responsible for and Smith Associates can supply you with the correct SOP, Work Instruction or form to meet your needs. All you have to do is review, approve and implement.

Implementation and Training of the Quality System can be provided upon request, either online or on-site.

Quality System Audits

The FDA requires regularly schedules internal audits. An adjunct to this schedule is a third party inspection

The outside audit puts new and objective eyes on your system. Since your Quality System is a living document and may undergo changes purposely or sometimes inadvertently. Subtle changes or more obvious ones may occur without recognition and documented change to your SOPs. From our experience, a good many of the 483s occur when the SOPS and the actual procedure do not match.

Our objective is to identify those non-conformances that may occur by omission or commission and assist your company in correcting any anomalies.

Pre-Audit Preparation for FDA Inspections

A pre-FDA audit can assist your company in preparing for your audit, identify any trouble spots and resolve them before the FDA audit rather than responding to FDA 483 observations after the audit.

Can I have a consultant during an audit?

Yes. Most companies do not realize that they may have a third party representative for their company during an FDA inspection, as an observer and also to assist in the response if any 483 Observation should occur. Smith Associates has represented companies as an on-site consultant during FDA inspections internationally and in the United States. Our resume includes Class III FDA audits for device PMAs, in-vitro diagnostic PMAs and Class I and II FDA audits.

The FDA just called for an inspection next week, but my Quality System is not complete…now what?

And what a feeling that is to be ill prepared for a surprise inspection. We can help you fill in your Quality System gaps or provide an entire QS with our Implementation-Ready Quality System

FDA has scheduled an inspection…am I prepared?

A pre-FDA audit can assist you in preparing for your audit, identify any trouble spots and resolve them before the FDA audit rather than responding to FDA 483 observations after the audit.

Can I have an outside representative as my management representative during an audit?

Yes. Most companies do not realize that they may have a third party representative for their company during an FDA inspection. Smith Associates has represented companies around the globe from Class III breast implants and in vitro diagnostic companies to Class I GMP-required manufacturers.

The FDA just called for an inspection next week, but my Quality System is not complete…now what?

And what a feeling that is to be ill prepared for a surprise inspection. We can help you fill in your Quality System gaps or provide an entire QS with our Implementation-Ready Quality System.

483 Observations & Warning Letter Responses

483 Observations

How serious is a 483 Observation?

It is serious since the inadequacy of your response can lead to further FDA actions including a Warning Letter. The object of careful response is to avoid that escalation of review.

I have received 483 Observations after my FDA inspection, how do I know if I am answering them correctly?

A company's handling of responses to 483 Observations, Warning Letter and Recalls are critical to a company's survival in the present FDA regulation climate. A company's response must be timely, and comprehensive. Smith Associates has successfully assisted many companies in their responses to 483 observations to the FDA’s satisfaction.

I am not sure I can respond in 15 working days. Is this important?

Most responses must be returned to the FDA in 15 working days, so utmost haste when addressing 483 observations is critical. The FDA is looking for a response where appropriate actions are taken to remedy the observation. Your response must be timely but comprehensive. They want to review a response where a non –conformance is opened, the observation is investigated to determine the root cause of the observation and if warranted what corrective and preventive actions will be taken to correct the observation. Smith Associates is experienced in the responses in Class I, II and III products and has been highly successful in preventing a Warning Letter being issued as a result of an inadequate response.

Warning Letter Response

A Warning Letter has a profound impact on your business and business reputation. A Warning Letter is, in effect, just a continuation of the communication between the FDA and the company concerning your 483 response.

The Warning Letter will explain what has been accepted from your 483 response and what observation(s) were not appropriately addressed. Like the 483 response, a Warning Letter response must be comprehensive and address every aspect of the Quality System impacted by the correction.

Recalls and Corrections

A recall is a method of removing or correcting products that are in violation of laws administered by the Food and Drug Administration (FDA). Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective

Recalls may result from your 483 Observations or from a Warning Letter. Like all responses to the FDA, a Recall must be comprehensive and exhaustive in removing all recalled product from distribution. Smith Associates can provide the assistance to you company for:

  • Recall strategy
  • Health hazard evaluation
  • Coordination with FDA district office
  • Stock recovery – degree and depth of recall
  • Recall letter
  • Public warning
  • Recall status reports
  • Effectiveness checks